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QRS-Card™ Cardiology Suite 4.06 Software QRS-Blue™ ECG Device Operating Instructions
QRS-Card™ Cardiology Suite 4.06 Software QRS-Blue™ ECG Device Operating Instructions
Operating Instructions
CS406-10-F
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QRS-CardTM
4.06 Cardiology Suite Operating Instructions
CE Mark Declaration
The CE marking of conformity indicates that the device having this symbol on its
immediate label meets the applicable requirements of the European Medical Device
Directive.
These operating instructions are related to Cardiology Suite version: V406 (130716)
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Table of Contents
1. Safety ..................................................................................................9
1.1 Safety Conventions ............................................................................................ 10
1.2 User Responsibility ............................................................................................ 11
1.3 Warnings and Cautions ...................................................................................... 12
1.4 Symbols and Markings....................................................................................... 15
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Use the QRS-Card system under the direction of a physician. All users
should read and thoroughly understand the manual before use.[B1]
Pulse Biomedical, Inc. assumes no responsibility for any injury to anyone, or for any
illegal or improper use of the product, that may result from failure to use this product in
accordance with the instructions, cautions, warnings, or statement of intended use
published in this manual.
Software is Copyright 2007, Pulse Biomedical, Inc. All rights are reserved. The software
is protected by United States of America copyright laws and international treaty
provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy
of the software provided on the original distribution medium. The software may not be
copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-
perceivable form.
This is not a sale of the software or any copy of the software; all right, title and
ownership of the software remains with Pulse Biomedical, Inc.
For information about any Pulse Biomedical, Inc. product, call your nearest PBI office:
USA +1 610 666-5510
Europe + 49 7434 31603
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4.06 Cardiology Suite Operating Instructions
1. Safety
Chapter Contents:
1. Safety Conventions
2. User Responsibility
3. Warnings and Cautions
This chapter contains important safety and use information. Users should read and thoroughly
understand all notes, warnings and cautions before
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Warning statements describe conditions or actions that can result in personal injury or loss of life.
Caution statements describe conditions or actions that can result in damage to product or property.
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The intended use of this system is for Patients undergoing ECG Testing, and/or
ECG Stress, Blood Pressure, and Breathing analysis. The intended locations for use are in a
physicians office, hospital, exercise rehabilitation facilities, or similar areas. The intended user is
a trained medical professional and should have basic PC operational skills.
This product is designed to perform in conformity with the description thereof contained in this manual
and accompanying labels and inserts, when assembled, operated, maintained and repaired in accordance
with the instructions provided. A defective product should not be used.
Parts that are broken, plainly worn, missing or incomplete, distorted or contaminated should be replaced
immediately. Should any repair or replacement become necessary, we recommend that service be
performed at the nearest approved service center. The user of the product shall have the sole
responsibility for any malfunction, which results from improper use, faulty maintenance, improper
repair, damage or alteration by anyone other than Pulse Biomedical, Inc. or their authorized service
personnel.
Use of accessories other than those purchased from Pulse Biomedical or an authorized dealer or
distributor may compromise product performance and void Pulse Biomedical warranty.
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The QRS-Card devices are an integral part of a personal computer based diagnostic system. The user
shall adhere to all warnings in order to ensure safe and reliable performance of the system.
1. Only qualified service personnel should perform any service. Never use extension AC power
cords with the PC computer, chassis leakage current may increase.[u6]
2. Routinely inspect cables/leads assemblies for cracks, holes, tears, cuts, etc. that could present
problems to the system. [u7]
3. In case of ECG leadwire or cable replacement, use ONLY Pulse Biomedical lead wires and
cables.[u8] Use of cables other than those specified or sold by Pulse Biomedical may result
in increased emissions or decreased immunity of the QRS-Card Cardiology Suite
system.[B9]
4. If using a Treadmill with QRS-Card, use only FDA cleared treadmills.[u10]
5. If software CD becomes unusable, software can be downloaded from PBI web site
(www.qrscard.com).[u11]
6. For Bluetooth Device: Batteries should not be kept beyond the manufacturers published
shelf life.[u12]
7. Use only devices sold by or recommended by PBI.[u13]. Contact PBI for further assistance,
included sanctioned devices to interface with PBI system
8. For proper electrode placement, please see the diagram on the QRS-Card Device label or
in the QRS-Card Cardiology Suite software.[u14]
9. Do not connect the patient cable to anything other than the QRS-Card Device. Be sure you
know how to properly connect the patient cable to the QRS-Card.[u15]
10. PBI products should only be maintained and serviced by PBI factory personnel.[u16]
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11. The personal computer (non-medical electrical equipment) shall be situated outside the
patient environment (reference IEC 60601-1-1). Ensure that the computer and printer are
more than 6 feet away from the QRS-Card device and 6 feet away from the patient.[u17]
Do not place a telephone near the device.
12. Personal Computers and peripherals are required to meet IEC 60950[u18]
13. PACEMAKER PATIENTS: The QRS-Card Cardiology Suite hardware and software does
not provide or detect pacemaker pulses. Do not rely on the QRS-Card Cardiology Suite
output or the heart rate meter for Pacemaker patients during cardiac arrest. Pacemaker
patients must be closely observed.[u19]
14. MODEM USAGE DURING ELECTRICAL STORMS: For patient's safety during Electrical
Storms, the telephone line to the modem and the patient ECG cable should NOT be hooked
up at the same time.[u20]
15. QRS-Card ECG device must be at least 6 feet away from the computer.
16. LOW BATTERY: If the QRS-Card Cardiology Suite System is used with a battery
operated computer, the low battery indicator warning of the computer must be checked
before using the system on any patients.
17. PROPER ELECTRICAL GROUND: Proper electrical grounding to the AC lines is an
absolute necessity for acquiring noise-free ECG recordings.
18. PATIENT DATA BACKUP: It is important for users to backup their patient ECG data
regularly. In the case of accidental hard disk data loss, backup data can be restored to the
hard disk.
19. SCREEN SAVERs that blank the computer screen must not be used while the QRS- Card
Cardiology Suite ECG system software is running.
20. Use the QRS-Card software as stand-alone software. Do not run other software
applications while running the QRS-Card software.
21. Do not use this device in areas where flammable, explosive, or anesthetic agents are used.
The device is not intended for use during anesthesia.
22. Electromagnetic Compatibility- When using the QRS-Card, electromagnetic compatibility
with surrounding devices should be considered and evaluated. The QRS-Card complies
with IEC 60601-1-2 limits for EMC.
23. Due to the shock hazard that can exist within the PC when the cover is removed, only
qualified service personnel should perform service. Never use extension AC power cords
with the PC computer, chassis leakage current may increase.
24. Erratic and/or non-rhythmic heartbeats, or artifacts can result in inaccurate ECG readings.
25. ECG lead changes during measurements can cause artifacts that can result in inaccurate
readings.
26. Changing patient positions (e.g. supine, sitting, etc.) during measurements can cause artifacts
that can give inaccurate readings.
27. Choose an ECG lead other than V5 for patients experiencing cardiac occlusion.
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28. Use during fibrillation or with cardioplegic agents will result in artifacts that can result in
inaccurate readings.
29. For better measuring results, select the optimum signal/lead for monitoring.
30. Avoid nearby electrical noise sources, if possible.
31. If questionable readings are obtained, re-check the patient's cardiac rhythms by an alternate
means before administering any medication.
32. Secure the PC Monitor with the computer on the cart (if used) so that it does not tip over.
33. Consult the PC Monitor book for proper connection between the computer and the monitor.
34. Operation of the computer under low mains voltage conditions is established by the user's
computer choice. Use only UL listed computers to avoid this potential problem.
35. If the QRS-Card fails, please refer to the troubleshooting section in the user manual.
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= Temperature Limitation
= Keep Dry
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4.06 Cardiology Suite Operating Instructions
We thank you for purchasing QRS-Card Cardiology Suite and trust that our product
will help you more efficiently manage your cardiology data.
We value your thoughts, comments and questions. Please contact Pulse Biomedical Inc
to provide feedback:
Computer Skills
This manual assumes that the users have necessary computer skills and are capable of
using Microsoft Windows based applications.
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In order to install and successfully use QRS-Card Cardiology Suite, your computer
must meet the following minimum requirements:
1. Windows based PC with Windows 7 and Windows 8 with a minimum of 4GB
RAM.
2. Windows-compatible keyboard, mouse, USB Port and CD-Rom Drive.
3. Color/TFT monitor with a minimum resolution of 1024 x 768.
(Optimal resolution: 1920 x 1200)
4. Color or Black and White Printer (optional)
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All PBI QRS-Card Cardiology Systems come with a software installation CD (you can
also download a full software version from our web site www.QRSCard.com). Before
installing QRS-Card Cardiology Suite on your computer, it is important that you
understand and follow the instructions below:
Upgrading from versions 4.0 or higher will not delete patient records or reports.[B22]
To upgrade QRS-Card Cardiology Suite follow the instructions below (Note: these
instructions are using Windows 7 operating system, for help with other operating
systems, contact PBI):
1. Uninstall the earlier QRS-Card Cardiology Suite.
- Open your Start Menu and select Control Panel
-
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- Scroll down to QRS Card Cardiology Suite, highlight it, and click
Remove. When it asks if you are sure, select Yes.
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For installation instructions, please see installation guide sent with your QRS-Card
System, located on the QRS-Card Cardiology Suite CD-ROM or at Pulse Biomedical
Website (www.qrscard.com)
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To power off QRS-Blue, press and hold the power button for a few seconds. The status
indicator light will flash rapidly and then power off. If the device is left unused for 20
minutes, it will automatically power off to conserve battery.
This section will guide you around the various parts of Pulse Biomedical QRS-Card
Cardiology Suite Software.
Title Bar Tool Bar
Menu Bar Test Tool Bar
Patients Test
Database
Test Preview
Title bar The title bar displays the name of the program and contains three buttons
on the far right that can be used to minimize, maximize and close the
QRS-Card Cardiology Suite.
Menu bar The menu bar contains additional functionality for the QRS-Card
Cardiology Suite.
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Tool bar The tool bar contains buttons that give you easy access to the most
common tasks in QRS-Card Cardiology Suite, such as testing modules.
Test Tool The Test Tool Bar contains buttons that allow you to work easier with
Bar saved tests. You can open, print, mail or compare ECGs and add or
delete tests.
Patients The Patients Test Database contains records for all of the tests
Test performed. In this area you can find a patient, see which tests were
Database recorded for that patient and see the kind of tests that were recorded. The
test database is sorted according to the criteria selected on the Patient
Database Toolbar (Name, ID, Date, Test)
Database You can sort the patient database by patient name, id, test date or type of
Toolbar test. The Quick Search Area allows you to quickly search for a test by
typing a couple letters or numbers you are looking for within the selected
search criteria. [KB28]
Test Preview The Test Preview displays a brief overview of the file selected.
Status & The Status message contains information about what version of QRS-
Warning Card Cardiology Suite you are running along with licensing
Messages information such as serial number and PID of your software license.
Warning messages seeking user attention also appear here.
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From the Master Screen select File > Resting > Setup OR
Simultaneously press CTRL + F2 OR
Click on the Rest ECG icon (If the "Show This Window" option in the
Resting Setup has been selected, the Resting Setup screen will automatically be
displayed. )
Show Electrode If selected, the electrode positioning diagram will be displayed before performing each
resting ECG test.
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Start Test When If selected, the test will automatically start once it is determined that the ECG trace
Measurements Valid measurements are valid. If not selected, the ECG will begin but the test will not start
unless the Save Strip icon is clicked on the Resting ECG toolbar.[B31]
Print ECG Report If selected, an ECG Test report will be printed automatically at the end of the test (based
on the tests selected in the Default Reports box of the setup screen) and will be saved
to the computer hard drive.
If unselected, no reports will print, but the test will be added to the test database.
Printing can be done anytime after the test is acquired.
View Test Record If selected, the ECG test record will be displayed automatically after the Resting ECG
Test is finished.
If unselected, after the test is finished, the software will return to the master screen.
Exit When All Tasks If selected, the program will return to the Master Screen when all the tasks selected for
Complete the Resting ECG test are completed. (NOTE: If unselected, this feature can be used to
save multiple Resting ECGs strips from the same test.)
Remote This option allows users to define a Remote Server to remotely display the ECG test in
Server[B32] real time. For more information, please contact Pulse Biomedical.
Screens Defines Default parameters for Screen display values during ECG
acquisition and viewing. E.G. Gain, Speed, Lead Display etc.
In the Acquisition tab you can set the default gain and speed to be displayed when the
ECG is being acquired. You can also define the leads you would like displayed by
formatting the leads on the right hand side.
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1 ld- defines the default lead displayed if you choose a one lead display
3 ld- defines the default leads displayed if you choose a three lead display
6 ld- defines the default leads displayed if you choose a six lead display
12 ld- defines the default leads displayed if you choose a twelve lead display
To Define the Leads:
3. Double click on the lead to change (II, V2, V5) and a drop-down
menu will open in which user can select a different lead.
4. When you are finished defining the leads, click Apply
In the View tab you can set the default view on the Page screen and the Rhythm
screen during dataview.
You can also define whether you would like the toolbar or grid displayed during ECG
view during dataview.
Follow directions above to change the parameters and leads.
ECG Filter
Electrical If selected, allows the user to apply a 50Hz or 60Hz electrical filter to the signal. The
Interference
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Artifact Rejection If selected by choosing Standard, artifacts such as those caused by muscle twitches or
noise will be filtered.
Default Reports: Selected reports can be printed (automatically or manually) as default reports to printer
attached to the computer.
Please see Appendix 3: Sample Resting reports.
Interpretation User can select if they want Cardiology Suite software to automatically
interpret measurements. Options are: 1) PBI algorithm, 2) HES algorithm, 3)
LEUVEN algorithm or 4) No interpretation.
Average Cycles Defines the number of beats averaged to make a complex ECG.
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A Resting ECG test can be executed using one of the following methods:
From the master screen, select File > Resting > Perform Test OR
Depending on your settings (see section 4.1 Resting ECG Setup), you may see the
electrode placement diagram or the setup screen, once you move through these screens
you will see the Resting ECG Patient Information card. The top half contains
information about the patient, while the bottom displays traces from leads attached to the
patient.
To use an existing patient from your database, click the Browse button and search for
the patient. To run a test on a new patient, fill out the fields on the Patient, Test and
Medication tabs. When this form is complete, click OK.
The QRS-Card Cardiology Suite Resting ECG Acquisition Screen will be displayed
and the test will begin.
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Depending on your settings, the ECG test will do a number of things. If you are using
default settings, the test will run for 10 seconds and automatically save the 10 second
ECG strip. For more about resting test setup, see section 4.1 Resting ECG Setup.
[KB33]
Save Strip Clicking this button will save an ECG strip for the time specified in Resting Setup (See
Section 4.1). This option allows user to save multiple ECG strips from one ECG test.
Note: If you are using default Resting Test settings, selecting this button is not
necessary as a 10 Second ECG strip is automatically saved.
Print ECG Clicking this button will print an ECG report. This option requires a HP PCL5 printer.
[B34]
Note: If you are using default Resting Test settings, this option is not necessary because
the 10 Seconds ECG trace is automatically saved and can later be printed.
Finish Test Clicking this button will finish the ECG test.
Note: If you are using default Resting Test settings, this option is not necessary as the
test will automatically terminate after 10 seconds.
After the test is finished, depending on user settings, reports will automatically print or
software will return to the QRS-Card Cardiology Suite Master Screen with test
previewed in the Workspace. You test will be saved in the Test Database.
To view (or edit) a Resting ECG test, highlight the desired test from the Cardiology Suite
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The test record will be displayed in the Cardiology Suite Resting Dataview screen. The
default view is a 4 x 3 lead view (see example below).
[KB35]
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Use the Edit option to view or edit information about the patient.
Patient-
In this area users can edit patient demographics.
Test-
Contains additional patient information.
Medication-
Contains patient medication information.
Signal-
Contains information on how the ECG was obtained such as the sampling and use of
filters. In this tab, you can also change Blood Pressure Information.
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6.3.2 View
4 x 3 Screen
This view shows 12 leads organized in 4 columns, 3 rows and a rhythm strip on the
bottom. Each lead (except for the rhythm strip) shows 2.5 seconds of data.
On the top of the screen you can review patient demographics, ECG measurements, Heart
Rate, Interpretation, Blood Pressure, Test Date, Location and Physician Confirmation.
On the top right hand side of the screen, ECG measurements are shown (PR, P axis, QRS,
R axis, QT/QTc and T axis).
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Users can edit the interpretation directly from this view by clicking inside the
Interpretation box. Click or to exit interpretation editing.
[KB37]
2 x 6 Screen
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[KB38]Co
mplex Screen
This view shows each lead and its average complexes.[B39]
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[KB40]
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Rhythm Screen
This view shows ECG rhythm data. Users can scroll through all data saved during the
test by using the navigation bar at the bottom of the screen.
[KB41]
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6.3.3 Summary
Pressing the Summary button provides summarized data for ECG measurements and
automatic ECG Interpretation.
Table Screen
leads.
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General Screen
Provides ECG Complex measurements. Users can override the automatic ECG
measurements by moving the measurements marker. (Drag markers using left mouse
button)
[KB42]
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P Wave Screen
provides P wave morphological measurement markers. Users can override the automatic
ECG measurements by moving the measurements marker. (Drag markers using left
mouse button)
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T Wave Screen
provides T wave measurement markers. Users can override the automatic T wave
measurements by moving the measurements marker. (Drag markers using left mouse
button)
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Hypertrophy Screen
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Interpretation Screen
[KB45]
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By clicking the icon in the Interpretation screen, user can update the custom
dictionary. Follow Edit Instructions at the bottom of the screen.
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6.3.4 Report
Clicking the Report button allows users to select reports to be printed, PDF reports to
be created or the report to be viewed in Microsoft Word (See Appendix 3 for Sample
Resting Reports).
Show Details Pressing this button will either hide or show printing details.
Printer Pressing this button with show printer details.
Output Under output you can select which printer you want to print to. Your
default printer will show as the first option (In this example, RICOH
Aficio is the default printer)
PCL5 Printer[B46] Selecting this option will print the report to the default printer
PDF File Viewer By selecting this option, the report will be printed to a PDF file and displayed on
the computer screen.
The Save button from Adobe Acrobat Reader will save the report in PDF format,
which can be printed or emailed by the user, if required.
Note: In order to print PDF File Viewer to computer screen, installation of
Adobe Acrobat Reader 6.0 or higher on user computer is required (also make
confirm that version of Acrobat Reader is selected under
\Utility\Configuration\Option\PDF. To confirm, select Detect)[B47]
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MS Word File Selecting this option will open the report in Microsoft Word. The save
Viewer button from Micrsoft work will save the report as a Word file for editing,
printing, etc.
Note: In order to view in Microsoft Word, installation of Microsoft Word
on user computer is required.
Use Color Selecting this button will allow user to print ECG reports in color
depending on printer options.
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QRS-Card Cardiology Suite 4.06 software allows user to record, store and print Stress
ECGs quickly and easily. The best way to get a good quality ECG is for the
administrator to be properly trained, to prep the patient correctly and to reduce
artifact/noise. [B48]
Once you have the patient prepped and the electrodes securely attached you can begin a
Stress ECG test.[B49]
The Stress ECG Setup screen is used to define settings for running a Stress ECG Test. It
is recommended that before performing your first test, you define the setup.
From the Master Screen select File > Stress > Setup OR
Simultaneously press CTRL + F3 OR
Click on the Stress ECG icon . (If the "Show This Window" option in the Stress
Setup has been selected, the Stress Setup screen will automatically be displayed. )
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[KB50]
Protocol Defines the Stress Test Protocol to be used during the Stress ECG
Test.
[B51]
Protocol Editor Users can edit and customize protocols using the protocol editer.
(See Appendix 7:Stress Protocols)
Controlled Device Defines the stress test exercise device (either treadmill or
ergometer). You can confirm device hookup by click the Try
button.[B52]
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Try Tests the functionality and the connection between the computer
and the Exercise device. To test a device,
Select the Device in the Controlled Device menu.
Click Test. The Configure Exercise Device screen appears.
Test Tab:
To test a device, click on the icons under Speed to increase and
decrease the speed of the device. Click on the icons under
Treadmill to increase and decrease the elevation of the device.
The Blood Pressure can also be tested to verify the automatic
blood pressure device interfaces with the software is functioning
properly.
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Limits Tab
Lists the limits of treadmill or ergometer driver.
Automatic Blood Pressure defines if Blood Pressure
measurements will be taken automatically by a BP machine
interfaced to the QRS-Card Cardiology Suite Software or
whether the program will prompt the user to enter the BP
manually.
If Automatic Blood Pressure is selected, the user will NOT be
prompted for blood pressure input unless the blood pressure tool
button is manually executed. [B53]
Display Options
Show This Window If selected, the Stress setup box will be displayed before the start
of each Stress ECG test.
If it is not selected, the Stress setup box will not appear at the start
of each Stress ECG test.
Trend Screen If selected, the Trend screen will be displayed during the Stress
ECG test.[B56]
View Test Record If selected, the ECG record will be displayed immediately after the data is collected and
the stress test is finished.
If unselected, the software will return to the master screen after the data is collected and
the stress test is finished.
Remote Server[B57] This option allows users to define a Remote Server to remotely display the ECG test in
real time. For more information, please contact Pulse Biomedical.
ST Segment Selects the display lead for the ST Trend Window.
Display
Normal Provides the display of ST for the user selected lead.
Maximum ST Automatically displays the ST values for the lead that has either
Elevation or the maximum elevation or the maximum depression.
Depression Lead
Maximum ST Displays the ST values for the lead that has the maximum ST
Elevation Lead elevation.
Maximum ST Displays the ST value for the lead that has the maximum ST
Depression Lead depression.
Save Strings Allows the user to mark and annotate abnormalities during a
Stress ECG Test.[B58]
Terminate Strings Ends the Stress ECG Test so the user can review any annotations
that have been made.[B59]
ECG Filter
Electrical This allows the user to apply a 50Hz or 60Hz filter to the signal.
Interference The filter can also be turned off by selecting None.[B61]
Artifact Rejection If selected artifacts, such as those caused by muscle twitches, will
be filtered.
Baseline Drift If selected, drift of the baseline will be minimized.
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Reduction
Reports
Demand If desired, a printout of the ECG trace can be obtained while the
test is running. Chose the number of pages to be printed ( 1 to 6
pages or a continuous printout). Start the Stress test. Click on the
Print ECG icon and the printout will start from that point. If
Continuous is chosen, the printout will continue until the Print
ECG icon is clicked again.
Target Heart Rate Defines whether the Target Heart Rate is to be calculated from the
patients age or be manually assigned.
ECG Acquisition
Recorder Defines the device that is being used to produce the ECG signal. To confirm device
connection, click Try. An ECG trace should appear. Please see device user manual
for more instructions on device setup and troubleshooting or or call Pulse Biomedical
technical support (610) 666-5510.
Length Defines the maximum length of the ECG trace, in seconds, that is
saved.
Average Cycles Defines the number of beats averaged to make a complex ECG.
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Pre-Test Phase
Exercise Phase
Recovery Phase
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A Stress ECG Test can be executed using one of the following methods:
From the master screen, select File > Stress > Perform Test OR
Depending on your setup (see section 5.1 Stress ECG Setup), you may see the electrode
placement diagram or the Stress ECG setup screen, once you move through these screens
you will see the Stress ECG Patient Information card. The top half contains
information about the patient, while the bottom displays traces from leads attached to the
patient.
To use an existing patient from your database, click the Browse button and search for
the patient. To add a new patient, fill out the fields on the Patient, Test and
Medication tabs. When this form is complete, click ok.
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The Stress ECG Acquisition screen will appear and an ECG test will start.
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Clicking on the blue in the upper right hand corner of the window will display the
toolbar. Clicking on the crossed out will hide the toolbar. [B62]
Advance Stage Begin Recovery Blood Pressure Save Strip Print ECG Pause Protocol Finish Test
Use the Advance Stage command to advance the Stress Test to the next Stage.
[B63][KB64]
To annotate or mark a Strip to print during final reports, press the button.
The Save Strip window will appear, allowing the user to select an annotation to
add to the strip. [B65]
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To print a real-time ECG strip, press the button on the Stress Status Bar.
To pause (and manually control) the exercise stage and the protocol, press the
button. Once you press the Pause Protocol button, a warning box will
appear. Click Yes to disable the protocol and control the exercise driver
(treadmill or ergometer) manually, Click No to ignore and go back to stress
ECG test.
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These additional buttons are then used to manually control the Exercise Device
(Treadmill or Ergometer).
To finish or stop the test, press the button. This button is usually pressed
while in recovery phase, however the test can be stopped anytime during a test.
Once the Finish button has been pressed, the Terminate Stress Test window will
appear. [KB67]User can select from predefined options or free type reason for
stopping the test.
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REPORTS:
Once the stress test has been finished, the Select Reports screen will appear which
allows user to print, create a PDF or view reports in Microsoft Word.
A list of reports will be on the left side. (For sample stress reports, see Appendix 4: Stress Sample
Reports.)
Show Details Pressing this button will either hide or show printing details.
Printer Pressing this button with show printer details.
Output Under output you can select which printer you want to print to. Your default
printer will show as the first option (In this example, RICOH Aficio is the default
printer)
PCL5[B68] Printer Selecting this option with send the selected report to the default printer
PDF File Viewer By selecting this option, the report will be printed to a PDF file and displayed on
the computer screen.
The Save button from Adobe Acrobat Reader will save the report in PDF format,
which can be printed or emailed by the user, if required.
Note: In order to print PDF File Viewer to computer screen, installation of
Adobe Acrobat Reader 6.0 or higher on user computer is required (also make
confirm that version of Acrobat Reader is selected under
\Utility\Configuration\Option\PDF. To confirm, select Detect)[B69]
MS Word File Selecting this option will open the report in Microsoft Word. The save button
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Viewer from Micrsoft work will save the report as a Word file for editing, printing, etc.
Note: In order to view in Microsoft Word, installation of Microsoft Word on user
computer is required.
Use Color Selecting this button will allow user to print ECG reports in color depending on
printer options.
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7.3.1 Edit
Test Screen
- Contains additional patient information.
Medication Screen
- Contains patient medication information.
Signal Screen
- Contains information on how the ECG was obtained such as the sampling and use
of filters. In this tab, you can also change Blood Pressure Information.
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7.3.2 View
Select View to review (and edit) acquired Stress Test ECG data in various formats.
Page Screen
The Page screen shows a full disclosure view of the complete stress test. The example below shows the
default view. As you can see, the Rhythm button is selected and the rhythm view is shown below the
Full Disclosure View.
[KB70]
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Complex Screen
The Complex Screen shows average complexes during different stages of the Stress Test.
The example below shows the default view. As you can see, the Rhythm button is
selected and the rhythm view is shown below the Average Complex View.
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Strips Screen
Shows:
a. Automatically Selected Arrhythmia Strips
b. Stress Event Strip (e.g. every minute save for Bruce protocol)
c. Custom Save/Annotated Strips.
The strips shown with time stamps highlighted in yellow are the ones that are marked to
be printed. These strips can be marked and unmarked by using the tool bar buttons for
marking/unmarking. [B71]
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7.3.3 Summary
This selection is used to review Stress Test Summary Data. This data include Stress Summary,
Table Data for Stress Test and Summarized Stress Test Interpretation.
Summary Screen
Shows summary information of stress ECG test and the reason for the termination of the
test (user can overwrite information in the Reason for termination box).
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Table Screen
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Interpretation Screen
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By clicking the icon in the Interpretation screen, user can update the custom
dictionary.
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7.3.4 Report
Clicking the Report button allows users to select reports to be printed, PDF reports to
be created or the report to be viewed in Microsoft Word (See Appendix 3 for Sample
Resting Reports).
(For sample stress reports, see appendix 4: Sample Stress Reports.)
Show Details Pressing this button will either hide or show printing details.
Printer Pressing this button with show printer details.
Output Under output you can select which printer you want to print to. Your
default printer will show as the first option (In this example, RICOH
Aficio is the default printer)
PCL5 Printer[B73] Selecting this option will print the reports to default printer
PDF File Viewer By selecting this option, the report will be printed to a PDF file and displayed on
the computer screen.
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The Save button from Adobe Acrobat Reader will save the report in PDF format,
which can be printed or emailed by the user, if required.
Note: In order to print PDF File Viewer to computer screen, installation of
Adobe Acrobat Reader 6.0 or higher on user computer is required (also make
confirm that version of Acrobat Reader is selected under
\Utility\Configuration\Option\PDF. To confirm, select Detect)[B74]
MS Word File Selecting this option will open the report in Microsoft Word. The save
Viewer button from Micrsoft work will save the report as a Word file for editing,
printing, etc.
Note: In order to view in Microsoft Word, installation of Microsoft Word
on user computer is required.
Use Color Selecting this button will allow user to print ECG reports in color
depending on printer options.
Save Button
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The QRS-Card Cardiology Suite offers advanced Holter ECG technology with many
standard features in one package. By using advanced analysis techniques QRS-Card
Cardiology Suite provides accurate results that can be systematically reviewed with
minimal technician involvement. [KB75]
The best way to get a good quality ECG is for the administrator to be properly trained, to
prep the patient correctly and to reduce artifact/noise. [B77]
Once you have the patient prepped and the electrodes securely attached you can begin a
Holter ECG test.[B78]
See Holter Hardware user guide for information on how to begin the test. Once the
patient returns, remove memory card from Holter recorder and place in the card reader
attached to your computer.[B79]
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The Holter Setup screen is used to define settings for downloading a Holter ECG Test. It
is recommended that before downloading your first test, you define the setup.
From the Master Screen select File > Holter > Setup OR
Simultaneously press CTRL + F5 OR
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Device Select the device you have recorded Holter ECG data with. Options
include:
- Braemar DXP1000 (also used for Braemar DL800 and Braemar
DL900)[B80]
- Cardioline File Importer
- Datrix DR512 VX3 (128 Hz)
- Datrix DR512 VX3 (224 Hz)
- CardioRemote Holter
- Rozin File Importer
Record Use this option to select file you are downloading from. To select a
different file, click the Browse button.[B81]
Show this If selected, the Holter Setup window will display each time you are
Window downloading Holter ECG tests.
Enter Patient If selected, the Holter ECG Patient Information dialog box will
Demographics appear during Holter ECG download.
Edit If selected, the Holter test will open for editing after it is downloaded.
Beats Opens the Configure Beat Detection dialog box. There are 3 tabs,
Noise, Beat Detect and Pacemaker.[B82]
Default Report Specifies the type(s) of final reports to be printed automatically after
the Holter test is completed.
Initialize Patient data can be uploaded to the recorder. (Note: Only if recorder
Recorder supports this option)
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When finished defining setup, click Ok to begin downloading Holter ECG data.
Enter patient information by filling in the Patient, Test and Medication tabs. Click
Ok when complete.
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the desired Holter ECG Test and click the button on the toolbar
OR
Double click on the test to be viewed.
The test record will be displayed in the QRS-Card Cardiology Suite Holter ECG Dataview
screen.
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Patient Screen
- in this area you can edit patient demographics
Test Screen
- Contains additional patient information
Diary Screen-
- Used to add or remove strips to the patient diary
Medication Screen
- Contains patient medication information
Signal Screen -
- Contains information on how the ECG was obtained such as the sampling and
use of filters. In this tab, you can also change Blood Pressure Information.
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8.2.2 View
Select View to review (and edit) the Holter Test ECG data in various formats.
The View Holter ECG module has been divided into different categories (Beats,
Episodes, Page and Strips) to allow for easy navigation and reclassification of the Holter
ECG data.
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Beats Screen
Bins
= Normal
= Aberrant
= Atrial Paced
= Ventricular Paced
= Atrio-Ventricular Paced
Bins are displayed below which allows the user to view all similar beats within a single
template as a group and the beats from the selected Bin are displayed in the Rhythm Edit
Screen.
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To reclassify beats
1. Select the beat(s) from the Bins that you want to reclassify in the Rhythm Edit
Screen.
To select a single beat click on the R-wave. To select multiple beats drag the R-
waves that you want to include.
2. Click the desired reclassify button that you want the beat to be reclassified to.
[B84]
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[B85]
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Episodes Screen
R-R Interval
Episodes
List
Trend Screen
The Episodes Screen enables the user to review ECG data through the R-R interval
window and the trend window. Data in both windows is synchronized with the Rhythm
Edit Screen as the user highlights the data.
As the ECG data is analyzed the Episodes are evaluated against predefined criteria and
are stored in the following categories:
Fastest Rates
Slowest Rates
Bradycardia
Pause
Isolated VEB
VEB Pair
VEB Run
Bigemny
SVEB Pair
SVEB Run
Recorder Episode
STe Abnormalities
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To reclassify Episodes
1. Select the Episode(s) from the Episodes list that you want to reclassify in Rhythm
Edit Screen
To select a single Episode click on the R-wave. To select multiple Episodes drag the
R-waves that you want to include.
2. Click the desired reclassify button that you want the Episode to be reclassified to.
[B86]
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4. Select the Episodes you want the edit by clicking on multiple Episodes or click
Mark Row, Mark Page, or Mark All.
5. Click N, V, P, A, S, B, or X reclassify button to edit the Episodes
The selected Episodes will be reclassified and the ECG Edit window will be updated
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The selected episodes will be reclassified and the ECG Edit window will be updated
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Display Strips
These control which ECG strips are displayed in the Strips mode.
All - Use to display all strips for a category.
Marked -Used to display all marked strips from a category.
Unmarked - Used to display all unmarked strips from a category.
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Page Screen
The selected beats will be reclassified and the Rhythm window will be updated.
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Strips Screen
The Strips screen allows the user to review and select which Episodes should be printed
in the selected report. Strips are displayed in the following categories:
VPB
VPB Pairs
Bigeminy
SVPB
SVPB Pair
SVT
Pause/Asystole
Patient Episodes
Selected Strips
ST Episodes
Tachy/Brady
Fast rate
Slow rate
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Supraventricular Screen
Ventricular Screen
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Bigeminy Screen
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Paced Screen
ST Screen
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Interpretation Screen
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8.2.4 Expert
This tab contains additional functionality only available in our Extended and Elite
Software versions.
Pace Screen
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Afib Screen
ST Screen
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Device
Specify the ABPM device used.
Port
Defines which empty com port the device will be using or if a file is being downloaded.
Record
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Specifies the location of the data file to be downloaded, including the drive.
Show this Window
If this box is checked the Setup dialog box will appear before each ABPM download. If
the box is unchecked the Setup dialog box will not appear before each download. The
download will proceed in the predesignated fashion.
Enter Patient Demographics
Checking this box will allow for the entering of patient demographics while the ABPM
data is being downloaded. Click on the Finish button when data entry is completed.
After Download
Exit If the Exit option is selected, the program will wait in standby in the Acquisition
Screen after the ABPM file is downloaded.
Edit If Edit is selected, the ABPM file will be downloaded and then the Dataview
screen will appear to allow review and editing of the data.
Print The Print option will download the ABPM file and proceed with printing the
report selected.
Default Report
Allows for selection of a default report at the time of download. The type of report can
be changed after the download by opening the ABPM test and selecting File > Print
Report in the ABPM Dataview screen.
Upload Patient Data
The Upload Patient Data button allows the upload of ABPM data from the QRS system
to the ABPM Device.
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To view (or edit) a ABPM test, highlight from Main Screen the ABPM Test desired then click on the
button on the toolbar. OR
Double click on the Test to be reviewed.
When a ABPM test record is opened, the ABPM Dataview screen is displayed. Information about the
patient can be viewed and/or edited, data from the test viewed and reports printed. An outline of the
features and options displayed on the ABPM Dataview screen is given below, along with any available
links to other relevant topics.
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9.2.1 Edit
Use the Edit option to view or edit information about the patient and trace recalled from the database. The
Edit option can be executed by the following methods:
9.2.2 View
9.2.3 Summary
Pressing summary button provides summarized data for ABPM measurements (Summary, Hourly, Actual
Measurements) and location to type physician Interpretation.
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9.2.4 Report
Checked Off reports can be printed (automatically or manually) to printer attached to the computer.
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10. Spirometry
Coming Soon!
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Cardiology Suite software provides options of saving ECG data on the local
computer (or mobile phone) and also at the same time in the cloud (remote server).
Cloud ECG data is available for review/editing remotely using Cardiology Suite
Software or a standard Internet browser.
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12. Utilities
12.1 Topics
12.1.1 Configuration
Configuration Section is used to setup various default parameters of using QRS-
Card Cardiology Suite Software. These options include:
Reporting
Database
Measurements
Options
GDT Interface
Real-Time Print
Email
Login
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REPORTING
Use the Reporting Configuration Property Sheet to set the default values for
reporting ECG results. Access the property sheet by the following method:
Select Utility > Configuration and click on the Reporting tab in the Configuration
Setup property box.
Complex
Gain- Defines the Gain for ECG complexes to be printed on the Stress
ECG reports. Options are 5, 10, 20 or 40 mm/mV.
Speed- Defines the Speed for ECG complexes to be printed on the Stress
ECG reports. Options are 25, 50 or 100 mm/sec.
Lead 1- Defines the 1st complex lead to be printed on the Stress ECG
reports.
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Lead 2- Defines the 2nd complex lead to be printed on the Stress or Hi-
Res ECG reports.
Lead 3- Defines the 3rd complex lead to be printed on the Stress or Hi-
Res ECG reports.
Rhythm
Gain- Defines the Gain for the ECG to be printed on the ECG reports.
Options are 5, 10 or 20 mm/mV.
Speed- Defines the Speed for the ECG to be printed on the ECG reports.
Options are 5, 10, 25 or 50 mm/sec.
Lead 1- Defines the 1st ECG Lead for the three lead ECG reports.
Lead 2- Defines the 2nd ECG Lead for the three lead ECG reports.
Lead 3- Defines the 3rd ECG Lead for the three lead ECG reports.
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DATABASE
The Database property sheet allows the user to select the location that the ECG data files
will be stored. This property sheet can be accessed by the following method:
Select Utility > Configuration and select the Database tab in the Configuration
Setup property
box.
Root: Defines the default root directory for all ECG data files. To change the
directory, click the Browse button and select the directory.
Reset- use the Reset button to bring all parameters back to their factory defaults.
Logging- Customer support may ask for this to be selected in order to pinpoint a
problem.
OPTIONS:
Select Utility > Configuration and select the Option tab.
This option selects ST Values parameters, Multitask message display, PDF File Viewer
Setup and Word program setup.
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EMR:
This option is for EMR interfacing setups. For more help with setup, please contact
Pulse Biomedical Technical support team.
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REALTIME PRINT
Select Utility > Configuration and select the Real Time Print tab.
This option is used to Enable or Disable Real Time Printer and to Setup Real Time Report Parameters.
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EMAIL
Select Utility > Configuration and select the EMAIL tab.
This option is used to Setup Server Parameter for Sending and Receiving ECGs via
Email.
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LOGIN
Select Utility > Configuration and select the LOGIN tab.
Systems Access: Allows user to set unique user name and password to prevent
unauthorized access to the Cardiology Suite & Remote/Cloud Database Server
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Cloud Access : User will set up his Remote/Cloud Server Account which will be
activated through a verification email to the email address provided by the user
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12.1.2 Physicians
Names of attending and referring Physicians database are stored using this option.
Import: Select to Import an existing text format Physician list into Physician database
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12.1.3 Clinics
Select Utility > Clinics then property box will appear
This option is use to Enter Clinics Names for a multi-practice medical office.
Import: Select to Import a text format Clinics names into Clinics database
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12.1.4 Technicians
Select Utility > Technician then property box will appear
This option is used to input Technicians name acquiring the ECG data
Import: Select to Import a text format technician names into technician database
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Select Utility > Import Records then property box will appear
Cardiology SuiteTM will access the backup database. Select the file you would like to
import and click Open. Cardiology Suite will import the selected file into your test
database.
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The Import Report option is used to import any new ECG report formats supplied by
Pulse Biomedical or to import any changes made to already existing report formats.
To import a report format, highlight the desired report and click Open. The new report
will be imported into your report database.
To make changes to the format of an existing report go to Windows Explorer. In the
directory containing the QRS-CardTM software, click on the report to be modified with
the right mouse button. Select Open. The existing report format will open on the
Notepad. Make the desired changes and save them. Return to the QRS-CardTM software
and the Import Report option. Highlight the modified report and click on Open. The
modified report is now ready for use.
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The Queue System places the ECG traces from the patient Tests database in the queue
system. At a later time, the user can dump the queue to a printer, E-mail the traces, or
export the traces to an external file (one not connected to the QRS databases). Using the
Queue system, the user can also receive ECG traces via E-mail or import a trace from an
external file.
The system will display the QRS Queue System dialog box.
Dump Queue- Clicking on Dump Queue will dump the entire selected queue to
the appropriate output device and the Queue Dump dialog box appears. The
Queue Dump dialog box shows the status of the queue dump. Any errors that
occurred will be listed.
Delete Queue- Clicking on Delete Queue will delete all items in the type of queue
selected.
Reset Errors- Clicking on Reset Errors will reset any errors that occurred when
dumping a queue.
Add- Clicking on Add will cause the system to display the appropriate Add
dialog box for the selected output device. See the Available Queues below for
more information.
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Update Clicking on Update will bring up the Update QRS Queue Entry dialog
box. Details of the selected item can be edited in this dialog box. In particular,
the type of report selected for a particular queue item can be edited using this
option.
Delete Clicking on Delete in the bottom section of the dialog box allows the user
to delete individual items from a particular queue.
Print Queue
To add to the Print Queue, double-click on Printer under Available Queues in the Queue
Detail Dialog Box or highlight Printer and click on the Add button. The Add Entries to
QRS Print Queue Dialog Box will be displayed.
Select the test and the type of report desired, add any comments necessary and click on
Add. Click on the Close button to exit this dialog box. The selected traces will be copied
to the Print Queue. Select Dump and the traces will be printed.
To aid in finding an encounter, the user may sort the database by name, ID or date/time
the encounter was obtained by clicking on the appropriate heading name.
Mail Out
The Mail Out option allows the user to E-mail ECG traces.
Note: For best results, connect to the Internet before entering the Queue System.
To add to the Mail Out Queue, double-click on the Mail Out option under Available
Queues or highlight Mail Out and click on the Add button. The Add Entries to QRS Mail
Out Box Queue Dialog Box will appear.
Highlight the encounter to be E-mailed and using the directory option, enter the recipient
E-mail address. Click on Add to the queue. Click on Close to exit the dialog box. Click
on Dump Queue to start the E-mail process.
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Mail In
The Mail In option allows the user to receive ECG traces via E-mail.
Note: For best results, connect to the Internet before entering the Queue System.
As the Queue System is accessed, a message "Retrieving message X or X" will appear if
E-mail has been sent to you since you last logged onto the Internet. The Mail In option in
the Available Queue box will show the number of messages.
Highlight Mail In and click on Dump Queue. The messages will be dumped directly into
your database.
Note: Be aware that the time on the encounter is when the test was taken not when it was
e-mailed or dumped into the database.
Queue Export
Selecting the Export Queue option will allow the user to export ECG traces to an external
file.
To export a file(S) double click on Export under Available Queues or highlight Export
and click on the Add button. The Add Entries to QRS Export Queue Dialog Box will be
displayed.
Select the file(S) to be exported and click on Add Encounter. Click on the Close button
to exit this dialog box. The files will be copied to the Export Queue. Select Dump. The
selected files will be exported into the Windows Temporary (TAMP) Directory.
Queue Import
Selecting the Import Queue option will allow the user to import ECG trances from an
external file.
To add to the Import Queue, double-click on Import under Available Queues or highlight
Import and click on the Add button. The Add Entries to QRS Import Queue Dialog Box
will be displayed.
Select the file to be imported and the format to be used and click Apply.
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12.1.8 Rebuild
This selection can also be used if two or more databases needs to be combined
together into one database (e.g copy both database *.SCP files into qrsdb4\files
folder then select Rebuild command)
Rebuild Database may take longer with large data files like Holter ECG. Wait
times would be comparatively less in case of Resting and Stress ECG files.
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13. Logs
Log files are created each time the STWIN program is run. This file keep track of all
operation performed by the user. More importantly this files keep logs of any errors occur
during the usage of the program.
Viewing the file can very helpful in troubleshooting problems with the program.
Status
Use the Status command to display the status log. The Status command can be executed
by the following method:
From the Logs Menu select Status.
When the Status command is executed the system displays the Log View Dialog Box.
This log file shows the most recent events the system executed.
Error
Use the Error command to display the error log. The Error command can be executed by
the following method:
From the Logs Menu select Error.
Executing the Error command causes the system displays the Error Log View Dialog
Box. This log file shows the most recent errors that the system encountered.
Pressing MAIL tab in the Log View will send the log file directly to PBI technical
support.
Error Log file is the MOST IMPORTANT file for trouble shooting the QRS-
Card Hardware and software. During technical support call to PBI the information contains
in this file will assist PBI the most information to solve or diagnose the problem over telephone.
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14. Help
14.1 Contents
The Help Contents screen allows users to explore the Cardiology Suite user guide,
Quick Reference Guides and Brochures
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14.2 About
The Help About screen displays various information about licensing and software
versions.
License/Unlock Code:
Click to enter the PID available on the USB Dongle received with the
device
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Warranty
All repairs on products under warranty must be performed or approved by Pulse Biomedical, Inc.
Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty,
any product repair shall exclusively be performed by Pulse Biomedical, Inc certified service
personnel.
Before contacting Pulse Biomedical, Inc it is helpful to attempt to duplicate the problem and to
check all accessories to ensure that they are not the cause of the problem.
Repairs
If your product requires warranty, extended warranty, or non-warranty repair service, please call
first the nearest Pulse Biomedical, Inc Technical Support Center. A representative will assist you
troubleshooting the problem and will make every effort to solve it over the phone, avoiding
potential unnecessary return.
In case the return cannot be avoided, the representative will record all necessary information and
will provide a Return Authorization (RA) number, as well as the appropriate return address. A
Return Authorization (RA) number must be obtained prior to any return.
Pulse Biomedical, Inc does not accept returned products without an RA.
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Packing Instructions
If you have to return goods for service, follow these recommended packing instructions:
Remove all cables before packing, unless you suspect they are associated with the
problem.
Pack the device safely and include a packing list and the Pulse Biomedical, Inc Return
Authorization (RA) number.
It is recommended that all returned goods be insured. Claims for loss or damage to the product
must be initiated by the sender.
Limited Warranty Statement
Pulse Biomedical, Inc, Inc. warrants that the Pulse Biomedical, Inc Cardiology Suite computer
based product you have purchased meets the labeled specifications of the Product and will be free
from defects in materials and workmanship that occur within 1 year after the date of purchase.
Accessories used with the Product are warranted for 90 days after the date of purchase.
The date of purchase is: 1) the date specified in our records, if you purchased the Product directly
from us, 2) the date specified in the warranty registration card that we ask you to send to us, or 3)
if you dont return the warranty registration card, 120 days after the date on which the Product
was sold to the dealer from whom you bought the Product, as documented in our records.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not authorized by
Pulse Biomedical, Inc, and 4) accidents.
If a Product or accessory covered by this warranty is determined to be defective because of
defective materials, components, or workmanship, and the warranty claim is made within the
warranty period described above, Pulse Biomedical, Inc will, at its discretion, repair or replace
the defective Product or accessory free of charge.
You must obtain a return authorization from Pulse Biomedical, Inc to return your Product before
you send it to Pulse Biomedical, Incs designated service center for repair.
Pulse Biomedical Inc. makes no warranties, either expressed or implied, regarding the QRS-
Card Cardiology Suite 4.06, its merchantability or its fitness for any particular purpose, with
the exception of any limited warranties which are disclosed in this manual. The exclusion of
implied warranties is not permitted by some states. The above exclusion may not apply to you.
This warranty provides you with specific legal rights. There may be other rights that you may
have which vary from state to state.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. PULSE
BIOMEDICAL, INC'S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR
OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT. Pulse Biomedical IS NOT
RESPONSIBLE FOR ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING
FROM A PRODUCT DEFECT COVERED BY THE WARRANTY.
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PBI has provided you with a high quality QRS-Card Cardiology Suite device. When
the QRS-Card Cardiology Suite is used in conjunction with a computer to acquire ECG
data from a patient:
- It is important that the computer you are using with the QRS-Card Cardiology
Suite be of high quality with low electrical noise generation. If you have not
purchased your computer system from PBI or do not have the list of approved
low-noise computers in the marketplace, please call us for assistance.
- It is important that the Electrical Ground to the AC mains be properly grounded
and in good working order.
- It is important that no electrical noise be generated by any equipment in the
vicinity of the QRS-Card Cardiology Suite ECG machine.
PBI has tested your QRS-Card Cardiology Suite for the best ECG performance.
If you find electrical noise in the signal during a patient ECG, please check the following
before calling PBIs technical support line:
- Check that the patient is properly prepared and the lead connections are tightly
installed.
- Check the ECG environment to see if there is other electrical equipment present
that may be creating the electrical noise.
- Check your computer brand and model to make sure they are from an approved
manufacturer.
Electrical noise can be controlled if the above noise detection steps are investigated and
corrected.
For any further help, please call Pulse Biomedical Inc. at 610-666-5510.
Before calling PBI please note the serial number of your QRS-Card Device.
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[B91]
Reusable Electrodes
Each electrode must be attached securely. The electrode paste, gel, or cream must cover
an area the size of the electrode, but must not extend beyond it, especially on the chest.
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When you connect the electrodes to the patient, make sure that the electrodes
and their connectors do not contact other conducting parts (including earth).
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13090: QT Report
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PBI has designed its Stress Protocol for maximum flexibility. Users can select a
standard, predefined protocol like Bruce, Modified Bruce, etc or they can define their
own custom protocol.
Protocols supplied with QRS-Card Cardiology Suite consist of three Phases (Pre-Test,
Exercise, Recovery). Each Phase is subdivided into stages. Each stage can have a
number of events associated with it (Ex: take blood pressure, increase elevation, increase
load, print ECG segment).
Note: Within the Pre-phase user intervention is required to move on to the next stage.
o Supine-
ECG monitored/acquired during supine stage.
User must click the Advance Stage button to move to next stage.
o Hyperventilation
ECG monitored/acquired during hyperventilation stage.
User must click Advance Stage button to move to next stage.
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o Warm-up
ECG monitored/acquired during warm-up stage to check the
quality of the ECG/ lead placement
User must click Advance Stage button to move to next stage.
2. Exercise
o ECG monitored/acquired during exercise phase.
o Usually this phase consists of multiple stages (ex: Bruce protocol has 8
stages).
3. Recovery
o ECG monitoring after completing of the exercise phase
o Usually this phase consists of one stage.
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PBI designs, manufacturers and markets both the hardware and software components of a
diagnostic, twelve-lead ECG system for use with a Windows personal computer. PBI
QRS-Card Cardiology Suite was the first FDA approved PC-based ECG system,
receiving approval in 1991.
During the initial years, PBI invested in research and development while establishing a
corporate presence in the ECG marketplace through exhibiting at the American Heart
Association and American College of Cardiology conferences.
Through research and development Cardiology Suite has progressed from a separate,
DOS based insert able PC card to our newest FDA Bluetooth/USB system.
PBI owns all proprietary hardware design and has complete ownership to the source code
for Cardiology Suite software, including its own Automatic ECG interpretation
algorithm, Automatic ECG measurement algorithm, high-resolution signal averaging
algorithms and Holter ECG analysis algorithms.
PBI sells its products through independent dealers worldwide. QRS-Card Cardiology
Suite is used in over 50 countries worldwide and has sold its products on an OEM basis
to a number of companies.
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Appendix 9: Glossary
Bluetooth An open wireless protocol for transmitting data over short distances
libraries, etc.
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QRS-Card Cardiology Suite system needs special precautions regarding EMC and
needs to be installed and put into service according to EMC information provided in
Appendix 10.[B92]
Portable and mobile RF communications equipment can affect QRS-Card
Cardiology Suite system.[B93]
Table 1:
Guidance and manufacturers declaration electromagnetic emissions[B94]
The QRS-Card Cardiology Suite system is intended for use in the electromagnetic environment
specified below. The customer or the user of the QRS-Card Cardiology Suite System should assure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment- guidance
RF emissions Group 1 The QRS-Card Cardiology Suite system uses RF
CISPR 11 energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B The QRS-Card Cardiology Suite system is suitable for
CISPR 11 use in all establishments other than domestic and those
Harmonic emissions Not applicable directly connected to the public low-voltage power
IEC 61000-3-2 supply network that supplies buildings used for domestic
Voltage Not applicable purposes.
fluctuations/flicker
emissions
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The QRS-Card Cardiology Suite should not be used adjacent to or stacked on other
equipment and that if adjacent or stacked use is necessary, the QRS-Card Cardiology
Suite system should be observed to verify normal operation in the configuration in which
it will be used.
Table 2:
Guidance and manufacturers declaration electromagnetic immunity
The PBI QRS-Card Cardiology Suite system is intended for use in the electromagnetic environment
specified below. The customer or the user of the PBI QRS-Card Cardiology Suite system should assure
that it is used in such an environment.
Immunity Test IEC 60601 Compliance level Electromagnetic environment-
Test level guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or
discharge (ESD) ceramic tile. If floors are covered
8 kV air 8 kV air with synthetic material, the relative
IEC 61000-4-2 humidity should be at least 30%.
Electrical fast 2 kV for power Not applicable No power supply lines
transient/burst supply lines
<5 % Ur (>95 %
dip in Ur) for 5 s
Power frequency 3 A/m Power frequency magnetic fields
(50/60Hz) magnetic should be at levels characteristic of a
field typical location in a typical
commercial or hospital environment.
IEC 61000-4-8
NOTE Ur is the a.c. mains voltage prior to application of the test level
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Table 3:
Guidance and manufacturerss declaration- electromagnetic Immunity
The PBI QRS-Card Cardiology Suite system is intended for use in the electromagnetic environment specified
below. The customer or the user of the PBI QRS-Card Cardiology Suite system should assure that it is used in such
an environment.
Immunity IEC 60601 test Compliance level Electromagnetic environment- guidance
Test level
Portable and mobile RF communications equipment
should be used no closer to any part of the PBI QRS-
Card Cardiology Suite system, including cables,
than the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the PBI QRS-Card
ECG is used exceeds the applicable RF compliance level above, the PBI QRS-Card ECG should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocation the PBI QRS-Card ECG
b
Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3V/m
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The PBI QRS-Card provides high quality ECG at the expense of RF susceptibility. This position is justified twofold:
1) The morphology of the ECG waveform is maintained at the highest possible quality level. 2) Users of the QRS-
Card are trained medical professionals that recognize ECG artifacts including RF interference, and thereby make the
ne ssary corrections.
All semiconductors and ICs, whether analog or digital, demodulate RF signals: a process sometimes called audio
rectification. Digital circuits exhibit more noise immunity than analog circuits. Highly sensitivity patient coupled
analog circuits, such as those used in ECG devices, exhibit the least noise immunity.
It is possible to design analog circuits to demodulate less RF signals, but the problem cannot be eliminated. Shielding
and filtering techniques reduce the levels of those RF signals that actually get through to the circuits. Shielding is
never 100% effective, which forces the design into analog filtering. Analog filtering of cardiac signals distorts the
morphology of the ECG waveform. Analog design requires a tradeoff between maximum signal quality and minimum
RF noise. The PBI QRS CardTM uses minimum analog filtering to produce the highest fidelity ECG morphology, the
tradeoff permits higher RF signal noise. The improved ECG signal quality justifies the increased RF susceptibility.
Users of the PBI QRS CardTM are trained medical professionals. These experts recognize interference from RF sources
and identify interference on the ECG waveform, both during acquisition and when reviewing collected data. In
addition, experts adjust electrodes and prepare the patient to minimize RF interference, motion artifact and other
external interference for each test. This fact lends credence to the idea that increased sensitivity can be maintained in
the device, while maintaining safety and effectiveness.
Hand-held mobile transmitters (such as walkie-talkies, handyphones, cellphones, radio-telephones, mobile phones,
etc.) use up to 4W of RF power and can be close enough to expose equipment to electric fields in excess of the 3V/m or
10V/m typically required by medical equipment EMC standards. Mobile transmitters used by the emergency services
can be up to 10W RF power, whilst (legal) vehicle transmitters can be up to 100W. These facts point out that there is
no safe level of EMC immunity, as transmitting device become more powerful and portable.
Due to the ubiquity of hand-portable and vehicle mobile radio transmitters, this is a common problem which very few
EMC or safety standards address.
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Table 4:
Recommended separation distance between portable and mobile RF communications equipment
and the PBI QRS-Card Cardiology Suite system
The PBI QRS-Card Cardiology Suite system is intended for use in an electromagnetic environment in
which radiated disturbances are controlled. The customer of the user of the PBI QRS-Card Cardiology
Suite system can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the PBI QRS-Card Cardiology
Suite system as recommended below, according to the maximum output power of the communications
equipment
Rated Separation distance according to frequency of transmitter
maximum m
output
power of 150 kHz to 80MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
transmitter
d = 1.2P d = 4.3P d = 2.3P
W
0.01 0.12 0.43 0.23
0.1 0.37 1.4 0.74
1 1.2 4.3 2.3
10 3.7 14 7.4
100 12 43 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
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Channels : 12
Size : 4.0 x 2.5 x 1.0 (101.6mm x 63.5mm x 25.4mm)
Weight : 4.5 ounces (127.6 grams)
Sampling rate : 240Hz, 500Hz 12 ch.
Digital Resolution : 5 V
Input dynamic range : 10 mVpp
Input Offset Range : 300 mV
Frequency Response : 0.05 to 150 Hz (- 3dB)
CMMR : -60dB (minimum)
Input Impedance : > 100 M
Defib protection : Integrated
Operating Temp : 0 to 40 C
Storage Temp : -10 to 50 C
Relative Humidity : 25 to 95 % noncondensing
Atmospheric Pressure : 70 to 106 KPa
ECG Leads : Detachable 10 Lead (Banana or Snaps)
Connection : USB cable or Bluetooth
Power: USB : Self (Internally) powered via USB port <100mA
Bluetooth : Internally powered from 2 AA Batteries <100mA, Range up to 10
feet (3 meters)
Minimum Operating Time with 2 AA Batteries = 20 continuous hr
Output Port : TTL or Analog
R wave or Non-diagnostic ECGLead selectable
Default Gain 1000
ECG Measurements : Automatic
ECG Interpretation : Automatic
Data Storage : PC Hard Drive, Flash Card or SD Card
Printing : Laser / Inkjet; Color or Black & White
Reports : Multi-format; user customizable; PDF
Email : Microsoft Outlook or MAPI compliant
Screen Format : 1, 3, 6 or 12 Leads
ECG Speed : 5, 10, 25 mm/sec
ECG Gain : 5, 10, 20 mm/mV
ECG Filters : Digital 50/60 Line frequency; Muscle tremors 40 Hz
Baseline drift
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4.06 Cardiology Suite Operating Instructions
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QRS-CardTM
4.06 Cardiology Suite Operating Instructions
Introduction
PBI QRS-Blue ECG device converts a computer (PC) or a handheld device (Mobile
Phone) into a 12 lead Resting and Stress Digital ECG machine. Connection between
QRS-Blue is done via computer USB port or done wirelessly via Bluetooth Interface.
ECGs can be viewed in real-time on the computer screen or hand held device. ECG data
can be stored on the local memory or can be transmitted via Internet connection. ECG
reports are printed via computer attached standard printer.
Theory of Operation
During an ECG, the electrical signals generated by heart on the body are transferred from
the electrodes to the electronic circuit (ECG machine)
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4.06 Cardiology Suite Operating Instructions
Isolation Non-Isolation
A/D
Coupler
12 bit RX
Opto-
DB15 Input Connector
Patient Lead Wires 10
USB
Defibrillator
Output To
Computer
C ircuit
Coupler
Opto-
Trigger
1 Channel ECG
or
1Ch Analog TTL R wave
Pacemaker
or R wave out
+5V
from Computer
R-Wave
+5V (Isolated)
+ 3.3 V DC-DC
Power From USB
port of the computer
- 3.3 V
The QRS-Blue uses a DB15 Female connector for connecting a 10 lead patient
cable. Pin configuration for this connector is:
Pin # Signal
1 V2
2 V3
3 V4
4 V5
5 V6
6 Shield
7 N/A
8 N/A
9 RA
10 LA
11 LL
12 V1
13 N/A
14 RL
15 N/A
Defibrillator Protection:
In order to protect the circuit from high voltage generated from Defibrillator total of 10
Metal Oxide Varistors (MOV) used at the input of each lead.
Buffers:
Unity gain Operational Amplifier are used for creating high impedance input before input
of the ECG signal to the differential instrumental amplifiers.
Amplifiers:
Stage 1
8 Channels of ECG (lead I, Lead II, V1-V6) are amplified 5 times using Instrument
amplifiers and
Stage 2
Operational Amplifiers are used to amplify ECG signal 16.4 times
Stage 3
Operational Amplifiers are used to amplify ECG signal 2 times
Total amplification stage 1 to stage 3 is 164
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4.06 Cardiology Suite Operating Instructions
Hardware electronic circuit is used to detect R-wave pulses in the patient ECG signal.
Output of the R-wave is fed into the microcontroller, which in return provide an optically
isolated TTL Rwave signal output to pin 4 of RJ45 output connector.
Microcontroller:
QRS-Blue provides a Microcontroller to digitize the ECG signal and control the inputs
and outputs of the circuit. Microcontroller supports the digital controlling logic for the
circuit. The Microcontroller also supplies the 8 channels of 12 bit analog to digital
conversion used for ECG acquisition. Several digital I/O ports are used as inputs and
outputs for controlling other logic features. Two UARTS are used to communicate with
the USB and Bluetooth connections. The Analog ECG output signal port output requires
the pulse width modulation feature of Microcontroller.
QRS-Blue sampling rate can be adjustable between 240 Hz or 500 Hz via software
setup.
Signal Isolation:
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4.06 Cardiology Suite Operating Instructions
All digital signal isolation between patient and the computer is providing by using low
leakage current and high isolation voltage Optocouplers
Power Isolation:
For USB operation of QRS-Blue draws power from the computer USB port. Isolation
between USB power and patient is provided by medical grade IEC60601-1 approved DC-
DC power supply.
Data Communication:
QRS-Blue data communication to the computer is done either computer USB port or
through wireless Bluetooth connection. When USB interface is used Bluetooth
communication is automatically disabled.
Power:
Bluetooth mode of QRS-Blue requires 2 AA batteries for its proper operation. During
USB mode operation power is drawn from the USB port of the compute. A battery fuel
gauge circuit continuously monitors battery voltage and warns the user if the battery is
getting low in voltage.
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QRS-CardTM
4.06 Cardiology Suite Operating Instructions
QRS-Blue is made with high quality electronic parts and has no moveable parts which
makes its virtually maintenance free ECG device. Care must be taken for the cables used
(Patient lead wires and USB data cable) with the QRS-Blue machine so that wires
should not be damaged and should always be clean.
QRS-Blue is a digital ECG machine with auto calibration built in. QRS-Blue ECG
does not require any annual calibration of the ECG signals.
Batteries should not be kept inside the QRS-Blue device for extended period of time
when the device is not in use. Batteries must be replaced when low battery sign is shown
on the device LED and on the computer software screen.
QRS-Blue does not have any serviceable parts. For repairs or technical support call
Pulse Biomedical Inc. for a Return Authorization Number before sending the device for
repair to Pulse Biomedical Inc.
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